Kornimate/medical-research-clean huggingface dataset:
evaluation of quality of life and its influencing factors after va-ecmo in refractory cardiac arrest based on sf-36 score : a grenoble cohort study from 2006 through 2018

Conditions: Refractory Cardiac Arrest; ExtraCorporeal Membrane Oxygenation (ECMO)

Summary: if the extracorporeal membrane oxygenation (ecmo) improves survival in the management of refractory cardiac arrest (rca), this technique is still an invasive technique, not devoid of complications and requiring intensive care that can have serious consequences for patients. if the studies so far show an acceptable quality of life post ecmo in refractory cardiac arrest, the study looks about the quality of life of our patients in grenoble who survived a refractory cardiac arrest between 2006 and 2018 at the hospital university grenoble alps and the factors influencing this quality of life.


Eligibility criteria:
inclusion criteria: * adult \>18 years * admission to intensive care unit after a refractory cardiac arrest * hemodynamic instability after resumption of spontaneous cardiac activity. * non-opposition of the patient or his relatives * admission to intensive care unit from 2006 through 2018 exclusion criteria: * ecmo for hypothermia or drug intoxication. * comorbidity contraindicated the ecmo * patients dead before hospital discharge

Keywords: extracorporeal membrane oxygenation (ecmo) refractory cardiac arrest quality life assessement (sf36 questionnaire)
the influence of exercise on neuroplasticity and motor learning after stroke

Conditions: Stroke; Exercise; Rest

Summary: participants will complete 11 sessions. these include screening, 5 sessions where exercise or rest (according to group assignment) are paired with practice of a motor task, mri and transcranial magnetic stimulation (tms) before and after the intervention will be used to assess neuroplasticity (ability for the brain to reorganize and create new connections).

all participants will complete baseline sessions: 1) sub-maximal exercise test to ensure safe participation in aerobic exercise (testing session \[s\] 1); and 2) magnetic resonance imaging (mri) to assess brain structure and function, and 3) clinical assessments of motor function and activity. the mri and clinical tests will be completed on s2. between the exercise test and mri sessions individuals will wear accelerometers for 3 days to index usual activity levels. a custom computer program will then assign participants quasi-randomly to either the rest or exercise groups stratified on age, sex, and baseline motor function. cortical excitability will be assessed before and after either a single session of priming aerobic exercise, or rest, by group (s3). next, priming exercise will be paired with skilled motor practice for 5 sessions (s4-8). practice sessions will be separated by 48 hours. importantly motor learning will be assessed via delayed, no-exercise retention tests 24-hours (s9) and 30-days (s11) after the last practice session. activity levels (3 day accelerometry), tms and mri measures will be re-assessed after the second retention test (s10).

Eligibility criteria:
inclusion criteria: * between the ages of 40 - 85 * had a stroke at least 12 months ago * or are a healthy adult who does not have a history of neurodegenerative disorders * have the ability to understand english exclusion criteria: * contraindication to brain stimulation (such as a history of seizure or epilepsy) * contraindication to mri (such as a pacemaker, metal in the eyes / brain or fear of enclosed spaces) * neurodegenerative disorder ( such as parkinson disease, alzheimers disease or multiple sclerosis) * contraindications to exercise

Keywords: brain mri exercise rehabilitation tms
internet-based perioperative exercise program in patients with barrett's carcinoma scheduled for esophagectomy

Conditions: Barrett Esophagus

Summary: this study will evaluate, if an intensive individually adaptated training program via online supervision during neoadjuvant therapy will improve lung function and reduce pulmonary complications following esophagectomy for barrett's cancer.

patients undergoing surgery for esophageal cancer have a high risk for postoperative deterioration of lung function and pulmonal complications. this may be partly due to one-lung ventilation during the thoracic part of the operation. this often encounters for prolonged periods of reconvalescence and reduced quality of life, apart from socioeconomic disadvantages. physical preconditioning has become a crucial leverage to optimize fitness and lung function in patients scheduled for esophagectomy, in particular during the interval of neoadjuvant therapy.

Eligibility criteria:
inclusion criteria: * histologically proven adenocarcinoma of the esophagus or adenocarcinoma of the esophagogastric junction type i according to siewert's classification, clinical stages iib-iiic (t3/t4 and/or n+; m0) according to union internationale contre le cancer (uicc), 7th edition * resectable stage according to discussion in the local multidisciplinary tumor board (mdt) of the participating centers and patient medically fit for multimodality therapy (ecog performance status at least 1 or better, no severe impairment of cardiac, renal, hepatic, endocrine, bone marrow and cerebral functions) * planned abdominal-thoracic esophagectomy with gastric pull-up and intrathoracic or cervical anastomosis * cognitive ability of the patient to understand the perioperative program and to participate actively exclusion criteria: * presence of a second malignant tumor (unless curatively treated \> 5 years ago) * chemotherapy or radiochemotherapy in patient's history * orthopedic, rheumatologic, cardiovascular or neurologic (epilepsy, stroke, parkinson's disease, muscle wasting diseases such as amyotrophic lateral sclerosis or multiple sclerosis) contraindications for the sports program * inability to use the internet or no internet access * inability to communicate in german * each active disease, which hinders completion of the study * active alcoholism or illegal drug consumption within the last six months before study entry

Keywords: perioperative internet-based exercise program
a study to evaluate cardiovascular outcomes in patients with type 2 diabetes treated with itca 650

Conditions: Type 2 Diabetes

Summary: phase 3 study to evaluate cardiovascular outcomes in patients with type 2 diabetes treated with itca 650.


Eligibility criteria:
inclusion criteria: * hba1c \> 6.5% * history of coronary, cerebrovascular or peripheral artery disease exclusion criteria: * history of pancreatitis
study evaluating antibiotic utilization measures and control of extended-spectrum-lactamases (esbls)

Conditions: Bacterial Infection

Summary: * to determine the value of using piperacillin/tazobactam in reducing the cases of esbl producing e. coli or k. pneumoniae colonization and infection. * to determine the acquisition rate of esbl producing e. coli or k. pneumoniae, both pre and post intervention in the selected medical centers.


Eligibility criteria:
inclusion criteria: * patients admitted or transferred to the icu/pulmonary/hematology units. * patients of either sex, 18 years of age or older exclusion criteria: * pregnant and nursing women. female of childbearing potential without using any birth control methods. female of childbearing potential using oral contraceptives during study period. (note: penicillin and beta-lactamase inhibitors may prevent oral contraceptives from working properly, increasing the chance of pregnancy). * patients who have the contraindications of using tazocin (pipercillin/tazobactam) other exclusions apply.

Keywords: bacterial infection
ectopic adipose tissue, exercise training and il-6

Conditions: Adiposity

Summary: aim: exercise training improves the risk of cardiometabolic diseases; yet the underlying mechanisms are unclear. exercise induces release of il-6 from skeletal muscle. acute elevations in il-6 improve lipid and glucose metabolism, the latter partly through a delayed gastric emptying. physical inactivity causes accumulation of visceral fat (vat). visceral and epicardial adipose tissue (eat) is more inflamed than subcutaneous adipose tissue. thus, the investigators hypothesize that exercise-induced il-6 mediates the exercise-induced reduction in eat and vat. secondly, the investigators hypothesize that exercise-induced adaptations in glucose metabolism and gastric motility are dependent on il-6. finally the investigators hypothesise that both endurance and resistance exercise training reduce vat and eat. primary aim: to investigate the effects of exercise training on vat and to determine to what extend il-6 mediates this effect. secondary aims: 1) to determine whether 12 weeks of endurance and strength training can reduce the amount of eat. 2) to study whether the effects of exercise on glucose metabolism and gastric emptying are dependent on il-6. methods: inclusion: 70 inactive men and women, \>18 years, waist to height ratio \> 0.5 and/or waist circumference ≥ 88 cm (women); waist circumference ≥ 102 cm (men) design: a 12-week, double-blinded randomised, placebo-controlled exercise intervention study. intervention: subjects will be randomised to one of five groups: i) tocilizumab (il-6 receptor antibody) and endurance training, ii) placebo to tocilizumab and endurance training, iii) tocilizumab, no exercise iv) placebo to tocilizumab and no training, and v) placebo to tocilizumab, and resistance training. tocilizumab/placebo dose will be administered (according to standard recommendations) before the first training session, and maintained during the 12-week training program. training will be supervised to ensure intensity and compliance. subjects will be instructed not to change eating habits and informed that this study does not aim for a weight loss. statistical considerations: study investigators are blinded to treatment allocation. dropouts will be replaced. a sample size of 70 subjects is needed to detect a 10% change in visceral adipose, with a power of 80% and a significance level of 0.05.


Eligibility criteria:
inclusion criteria: * men and women * sedentary * waist to height ratio ≥ ½ and/or waist circumference ≥ 88 cm (women); waist circumference ≥ 102 cm (men) * age ≥ 18 y exclusion criteria: * pregnancy * diagnosed with diabetes (hba1c ≥ 48 mmol/mol or fasting glucose ≥ 7.0 mmol/l) * diagnosed with ischemic heart disease * atrial fibrillation * treatment with biologic rheumatic drugs, systemic prednisolone or other immunosuppressive treatments * health conditions that prevents individuals from participating in the exercise training intervention e.g. severe obesity * patients who cannot undergo mri scans (e.g. kidney disease, metallic implants or claustrophobia)
nurse-driven telephone intervention in improving side effects in cancer patients undergoing chemotherapy

Conditions: Breast Carcinoma; Head and Neck Carcinoma; Sarcoma

Summary: this clinical trial studies how well a nurse-driven telephone intervention improves side effects in patients with cancer who are undergoing chemotherapy. receiving calls from a nurse at home while receiving chemotherapy may improve the management of side effects and overall care in cancer patients.

primary objectives: i. to explore the feasibility of a proactive nurse-driven telephone triage intervention for patients with cancer receiving first-line chemotherapy in the ambulatory setting. secondary objectives: i. to explore the symptom experience of patients receiving a nurse-driven telephone triage intervention while receiving chemotherapy in the ambulatory setting. ii. to explore the satisfaction of patients receiving a nurse-driven telephone triage intervention while receiving chemotherapy in the ambulatory setting. iii. to explore the frequency of emergency room visits and hospital admissions for symptom management by patients receiving a nurse-driven telephone triage intervention while receiving chemotherapy in the ambulatory setting. outline: during standard of care chemotherapy, patients receive up to 18 telephone calls from a nurse using a standardized triage call script over 20 minutes.

Eligibility criteria:
inclusion criteria: * english speaking * newly diagnosed patients with a breast, sarcoma, or head and neck cancer diagnosis preparing to undergo first-line, standard of care chemotherapy (patients with head and neck cancer may be undergoing concurrent first-line chemotherapy and radiation treatment) * all chemotherapy treatment to be completed at the study institution exclusion criteria: * patients who have received previous chemotherapy treatment for cancer * patients who will be receiving chemotherapy on research protocols * pregnant patients, as they may be on unique treatment protocols outside standard of care or have symptom needs that are beyond the scope of this intervention * patients who are unable to verbalize (e.g. due to tracheostomy)
effect of postprandial hyperinsulinaemic hypoglycaemia on driving performance.

Conditions: Roux-en-Y Gastric Bypass; Postprandial Hypoglycemia; Driving Impaired

Summary: the primary objective of this study is to assess the effect of the natural course of postprandial hypoglycemia vs. a postprandial euglycaemic condition on driving performance in individuals with confirmed postprandial hyperinsulinaemic hypoglycaemia after gastric-bypass surgery.

despite the increasing prevalence of postprandial hyperinsulinaemic hypoglycaemia (phh), clinical implications are still unclear. anecdotal evidence from patients with phh suggest a high burden for these patients due to the recurrent hypoglycaemias with possibly debilitating consequences. it is well established, that even mild hypoglycaemia (plasma glucose of 3.4mmol/l) in diabetic and non-diabetic significantly impairs cognitive-motor functioning. of note, some of the cognitive aspects remain impaired for up to 75min, even when the hypoglycaemia is corrected. in addition to the hypoglycaemic blood glucose levels per se, the dynamics of the hypoglycaemia occurrence appears to play a role. it was shown in individuals with type 1 diabetes, that cognitive functions are affected more during a fast-fall than slow fall hypoglycaemia in the postprandial state. driving is a frequent daily activity which integrates various mental function including visual and auditory processing, motor skills, reasoning and problem solving. due to the potentially dangerous consequences, avoidance of hypoglycaemia-induced driving mishaps is of uttermost importance. several studies have evaluated the impact of induced, controlled hypoglycaemia in individuals with type 1 diabetes on driving performance using driving simulators but data in phh patients are currently lacking. assessing the potential impact of the natural course of postprandial hypoglycaemia on driving performance in phh patients will contribute to a better understanding of the consequences and relevance of this problem. the investigator will test the hypothesis whether driving performance during the postprandial glucose dynamics is impaired in patients with confirmed phh.

Eligibility criteria:
inclusion criteria: * aged ≥18 years * roux-en-y gastric bypass ≥1 year ago * phh defined as postprandial plasma or sensor glucose\<3.0mmol/l according to the international hypoglycaemia study group (1) and exclusion of other causes of hypoglycaemia * possession of a valid swiss driver's license. passed driver's examination at least 3 years before study inclusion. active driving in the last 6 months before the study. exclusion criteria: * clinically relevant weight changes (≥5%) within the past 3 months * incapacity to give informant consent * historical or current diabetes based on hba1c ≥6.5% without glucose-lowering treatment * haemoglobin level below 11 g/dl * ongoing treatment with glucose-lowering drugs, anorectic drugs, steroids or any medications known to affect gastric motility * active heart, lung, liver, gastrointestinal, renal or neurological disease * inability to follow study procedures * pregnancy or breast-feeding
evaluation of dose-titration of pramlintide during initiation of therapy in patients trying to improve glucose control

Conditions: Diabetes Mellitus, Type 1

Summary: this is a randomized, triple-blind, placebo-controlled, multicenter study to investigate the safety of pramlintide treatment using pramlintide dose-titration coupled with insulin adjustments in subjects with type 1 diabetes who are actively trying to improve their glycemic control.


Eligibility criteria:
inclusion criteria: * hba1c value between 7.5-9% * using multiple daily insulin injections
spine stereotactic body radiation therapy for metastatic epidural spinal cord compression

Conditions: Spinal Cord Compression

Summary: metastatic epidural spinal cord compression (mescc) is a frequent oncologic emergency that requires to be treated promptly. although direct decompressive surgery is the most effective treatment, surgery is only used in selected patients because most patients have a poor overall condition and short life expectancy. radiation therapy (rt), therefore, is the most commonly used for patients with mescc, but conventional rt alone can achieve modest neurologic outcomes. the hypothesis to use stereotactic body radiation therapy (sbrt) for mescc is that the rapid decompression of epidural mass, durable local control and subsequently improved neurologic outcomes compared to conventional rt are expected when mescc is treated with sbrt.

the definition of metastatic epidural spinal cord compression (mescc) * mescc is defined as both an evidence of cord compression by radiologic evaluation and a manifestation of clinical feature at the level of cord compression. * a cord compression by radiologic evaluation is defined as \< 3mm gap between epidural mass and true spinal cord or indentation of thecal sac at the level of clinical feature by mri. * clinical features include any or all of the followings: pain (local or radicular) or motor weakness or sensory change or incontinence. simulation -a computed tomography (ct) scan will be acquired with the use of intravenous contrast and planning mri will be also performed on the same day of simulation. spine sbrt - one to four sessions of sbrt will be performed. follow-up * patients need to be assessed at 1 week, 1 month and 3 months after the completion of sbrt and will be followed up at 3 month intervals thereafter. * pain score, neurologic examination, adverse events and simple x-ray of involved spine should be evaluated at every follow-up visit. * mri of involved spine will be performed at 3 months after the completion of sbrt. up to 43 patients will be enrolled in this study in samsung medical center, seoul national university hospital, and gachon university gil medical center.

Eligibility criteria:
inclusion criteria: * mescc is present. * localized spine metastases (c1 to l5 level); maximum 3 separate sites and maximum 2 contiguous vertebral bodies * performance state before the occurrence of neurologic symptoms : eastern cooperative oncology group 0-2 * age ≥20 * mri within 2 weeks is mandatory * paraspinal mass \< 5cm in maximum dimension * inoperable patients - refused or medically unfit for decompression surgery * life expectancy \> 3 months exclusion criteria: * retropulsed bony fragment causing cord compression * paraplegia ≥ 48 hours * histology preferred to perform the chemotherapy as the first option (e.g. lymphoma, myeloma)

Keywords: stereotactic body radiation therapy radiosurgery
deferoxamine plus chemotherapy for metastatic triple negative breast cancer

Conditions: Triple Negative Breast Cancer

Summary: the objective of the study is to evaluate the efficacy and safety of chemotherapy plus deferoxamine in metastatic breast cancer whose evaluation is stable disease with a trend of progression.

this is a phase ii, single center, prospective, single arm clinical trial. a lot of in vitro and in vivo study demonstrate that deferoxamine can increase anti-tumor effect. the objective of the study is to evaluate the efficacy and safety of chemotherapy plus deferoxamine in metastatic breast cancer whose evaluation is stable disease with a trend of progression after second-line. this study plans to recruit 30 subjects.

Eligibility criteria:
inclusion criteria: * has measurable metastatic triple-negative breast cancer, with at least 1 measurable lesion per recist criteria. * fail second-line or above anti-tumor treatment * evaluation is stable disease with a trend of progression. * minimum life expectancy 16 weeks * histological confirmation of breast cancer on primary tumour at diagnosis/on biopsy of metastasis * ecog performance status (ps) 0-2 with no deterioration over previous 2 weeks * normal organ function. * has signed a patient informed consent form. exclusion criteria: * eastern cooperative oncology group (ecog) score of ≥ 2 * patients with severe liver and kidney insufficiency * deferoxamine ingredients allergy * with the exception of alopecia, any unresolved toxicities from previous therapy greater than ctcae grade 1 before study treatment * inability or unwillingness to comply with study procedures, including inability to take regular oral medication * researchers consider it is not suitable for participation.

Keywords: deferoxamine plus chemotherapy objective response rate and safety
expanded access to avelumab for treatment of metastatic merkel cell carcinoma (mmcc)

Conditions: Metastatic Merkel Cell Carcinoma

Summary: expanded access to avelumab solution for infusion will be made available for adult patients with mmcc whose disease has progressed after receiving at least one prior chemotherapy.


Eligibility criteria:
inclusion criteria: * measurable metastatic merkel cell carcinoma according to response evaluation criteria in solid tumors version 1.1 (recist v1.1), has failed at least one line of adequately dosed chemotherapy in the metastatic setting and has subsequently progressed (where adequate dosing is defined as a minimum of 2 cycles) * not eligible for participation in any ongoing clinical trial for merkel cell carcinoma including the javelin merkel 200 study (nct02155647) * adequate hematological, hepatic and renal function as defined in the protocol exclusion criteria: * brain metastases * prior organ transplantation, including allogeneic stem cell transplantation * history of testing positive for human immunodeficiency virus (hiv) or known aids or active hepatitis b virus (hbv) or hepatitis c virus (hcv) infection * concurrent, active, malignant disease (other than merkel cell carcinoma) with the exception of basal or squamous cell carcinoma of the skin or carcinoma in situ as defined in protocol * previous or active autoimmune disease requiring systemic immunosuppressive therapy * known severe hypersensitivity reactions to monoclonal antibodies, any history of anaphylaxis, or uncontrolled asthma * clinically significant (that is, active) cardiovascular disease: cerebral vascular accident / stroke (\< 6 months prior to enrollment), myocardial infarction (\< 6 months prior to enrollment) unstable angina, congestive heart failure (new york heart association classification class ≥ ii), or serious cardiac arrhythmia requiring medication * persisting toxicity related to prior therapy of grade \>1 nci-ctcae v 4.03 (alopecia and sensory neuropathy grade ≤ 2 is acceptable) * being treated with chronic systemic corticosteroids or other chronic therapeutic immunosuppression * pregnant or lactating (for women of childbearing potential) * not using a highly effective contraception if the risk of conception exists

Keywords: metastatic merkel cell carcinoma expanded access program temporary authorisation for use avelumab